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Quality & Compliance
Zero recalls since 1979
Phytex invests in its people and resources to deliver the highest quality API supply with a proven track record of zero recalls since commencing operations in 1979.
We stand for integrity and reliability and have built our value-based culture on this behaviour, extending unparalleled technical support to meet commercial needs worldwide.
Regulatory compliance
Phytex maintains the highest quality standards, manufacturing in strict accordance with cGMP and ICH Quality Guidelines - ICH Q7 - as well as 21 CFR part 210 and 211.
Phytex holds current regulatory licensing with the Australian Therapeutic Goods Administration (TGA) as well as the U.S. Food and Drug Administration (FDA) (DMF 7406), in association with New Drug Applications and Abbreviated New Drug Applications with global pharmaceutical companies.
Phytex adopts the Pharmaceutical Inspection Cooperation Scheme Good Manufacturing Practice (PIC/S GMP) standards at every level, beginning with the harvest of botanical raw materials, through to quality assurance of procedures and quality control of upscaled commercial manufacturing practices.
Phytex is at the forefront of developing PIC/S GMP standards. Our scientists and quality unit team liaise directly with TGA personnel as well as sitting as active members on the TGA Industry Working Group on GMP (TIWGG).
Quality, reliability and compliance
Our commitment to quality:
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Continuous improvement for internal specifications ensuring improved product quality, stability and efficacy
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30+ years of refining validation processes ensuring batch to batch quality consistency
Our processes for reliability:
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Long-term partnerships with supply chain guaranteeing customers security of raw materials
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Australian owned and operated, and Australian sourced materials, guaranteeing supply from farm to lab
Our accountability to compliance:
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Zero product recalls in 40+ years complying with all monographs and regulations
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Products manufactured in regularly audited facilities according to Current Good Manufacturing Practice (cGMP) licensing and regulatory standards
Benchmark for quality
Phytex is a participant of the USP Donor Recognition Program and is the current provider of various purified Scopolamine derivatives and their impurities for USP Reference Standard qualification, as well as the development of USP monograph and methods, earning Phytex the Silver Donor Status worldwide.
Phytex made Scopolamine has been analysed to meet the necessary and stringent specifications of the U.S. Pharmacopeia, approved as the benchmark standard material for customers across the globe.
Australian owned, operated and sourced
Phytex is an Australian owned and operated business with 40+ years of experience servicing the global pharmaceutical industry.
Phytex works with Australian grown raw materials and has long-established relationships with its suppliers.
The Phytex facilities are certified to standards of the Australian TGA and U.S. FDA and are regularly audited.
The Phytex team comprises experts in Alkaloid extraction from natural sources with specialisation in Tropane, Indolizidine and Pyrrolizidine Alkaloids. Their focus is extraction (liquid/solid), isolation and purification of high quality, pharmacopeial compliant APIs as well as extracts and intermediates if required. The team is available to support partners through the entire drug development journey, from research and development, regulatory navigation to commercial scaling.
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